To evaluate the safety and efficacy of the endoscopically implanted ValenTx EndoPass™ System for treatment of adults with severe obesity. The EndoPass System is indicated for weight loss in adults with a body mass index (BMI) ≥35 and ≤ 50 kg/m2 who have failed more conservative weight loss methods.
* Single-arm, multi-center study conducted in up to 50 subjects at up to 5 sites. * Subjects will be implanted with the EndoPass device for up to 36 months. * Body weight, adverse events and device function will be monitored at monthly visits for the first year after implant and quarterly visits thereafter. * Additional follow-up data will include vital signs, hip and waist circumference, blood lab tests, endoscopic and esophagram assessments of the condition of the implanted device, quality of life and eating behavior questionnaires. * All subjects will be followed for 12 months after device removal. * A single device renewal may take place as needed after the initial implant. * Subject study participation may last up to four years, but is expected to vary with implant duration, which will be determined on a case-by-case basis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Subject is implanted with the device for up to 3 years.
Hospital Italiano de Mendoza / Clinica Quiriurgica
Mendoza, Argentina
Swiss Hospital / Especialidades Bariatrices
Monterrey, Nuevo León, Mexico
The proportion of subjects affected by serious adverse device effects (SADEs) as defined by International Standards Organization (ISO) standard 14155:2011.
The proportion of subjects affected by SADEs during the 12 months following their device implant
Time frame: 1 Year
12 Month Weight Loss in Kilograms
Mean reduction in bodyweight in kilograms from the day of implant to the 12 month post-implant follow-up visit.
Time frame: 1 Year
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